CN106955408A - Pad for patient interface - Google Patents

Abstract

The present invention discloses a cushion for a patient interface, particularly a patient interface for delivering a breathable gas to a patient, the cushion comprising: a base wall configured to be connected to a frame; a lower support liner a pad, which in use extends from the base wall towards the patient's face; and a membrane arranged to substantially cover at least a portion of the lower pad, the membrane comprising the bridge of the nose, cheeks and The chin area forms a continuously sealed nasal bridge, cheek and chin area, the nasal bridge and adjacent two cheek areas define an intersection, wherein the membrane of the nasal bridge area is at a height greater than the adjacent portions of the cheek areas at the intersection .

Description

Pads for Patient Interfaces

This application is a divisional application of the patent application with the application number 201110339739.1, the application date is November 1, 2011, and the invention title is "pad for patient interface". The patent application with the application number 201110339739.1 is the application number 200680002169.4 , the divisional application of the patent application with the filing date of January 12, 2006, and the title of the invention entitled "Patient Interface Pad".

Cross References to Related Applications

This application claims priority to U.S. Provisional Application No. 60/643,130, filed January 12, 2005, and U.S. Provisional Application No. 60/724,303, filed October 7, 2005, each incorporated herein in its entirety Reference.

technical field

The present invention relates to a cushion for a patient interface used in the treatment of Sleep Disordered Breathing (SDB), eg, with Non-Invasive Positive Pressure Ventilation (NPPV).

Background technique

The use of NPPV to treat SDB, such as obstructive sleep apnea (OSA), was pioneered by Sullivan (see US Patent No. 4,944,310). Devices for treating SDB include a blower that delivers air at positive pressure through a catheter to the patient interface. The patient interface can take several forms, such as nasal mask assemblies and oronasal mask assemblies. Typically, the patient wears a mask while sleeping for NPPV treatment.

Typically, mask assemblies include a rigid shell or frame and a soft face-contacting cushion. A cushion separates the frame from the patient's face. The frame and pad define a cavity that accommodates the nose or nose and mouth. The frame and pad are secured to the patient's face by the headgear assembly. Typically, headgear assemblies include straps that pass over both sides of the patient's face to the back or top of the patient's head.

US Patent No. 5,243,971 (Sullivan and Bruderer) describes a nasal mask assembly for continuous positive airway pressure (CPAP) with an inflated/molded seal that conforms to the contours of the patient's nose and face. The mask assembly has a face-engaging portion mounted to a shell that is sized and shaped to conform to the patient's nose region. The face engaging portion is in the form of an extensible membrane molded from an elastoplastic material. The extensible membrane and the housing together define a cavity. Pressurized air flowing into the cavity expands the membrane outward from the patient's face. The contents of this patent are incorporated herein by reference.

US Patent No. 6,112,746 (Kwok et al.) describes a nasal mask assembly and its mask cushion. The contents of this patent are incorporated herein by reference. The pad includes a generally triangular frame from which the membrane extends. The frame has an edge by which the cushion is attached to the mask body. The membrane has a hole in which the patient's nose is received. The membrane is spaced from the edge of the frame and has an outer surface substantially the same shape as the edge.

The padding of the patient interface can play a key role in the comfort and effectiveness of therapy. There are many different sizes and shapes of faces, which means a mask designed for one face type may not fit another. For example, Asian noses tend to have a low bridge, while Caucasian noses tend to have a high bridge. Using the wrong padding can lead to excessive air leakage and discomfort. While custom-made masks for each patient can address some discomfort, custom masks can be very expensive. Accordingly, manufacturers have sought to develop cushions that provide a comfortable and effective seal for a range of face sizes and shapes.

Contents of the invention

An aspect of the present invention is to provide a patient interface that provides more comfort to the patient while maintaining an effective seal.

Another aspect of the present invention is to provide a comfort pad for a patient interface that fits a wide range of facial shapes and sizes.

Another aspect of the invention relates to a pad comprising an underpad and a membrane, wherein the underpad and membrane have a substantially flat portion in the nose region of the pad.

Another aspect of the invention relates to a gasket comprising a base wall, a lower gasket, and a membrane, wherein the base wall and the lower gasket have a cross-sectional configuration that provides a variable spring constant around the perimeter of the gasket.

Another aspect of the invention relates to a patient interface wherein the base wall and frame connection of the cushion is offset inwardly relative to the outermost point of the cushion, eg, the outer membrane surface.

Another aspect of the invention relates to a cushion comprising a base wall and a lower cushion that slope or angle in the alar region of the cushion.

Another aspect of the invention relates to a cushion having a substantially constant mouth width independent of its facial height. Another aspect of the invention relates to a cushion for a patient interface that delivers breathable gas to a patient. The cushion includes a base wall configured to be connected to the frame, a lower support cushion extending from the base wall towards the face of the patient in use, and a membrane covering at least substantially a portion of the lower cushion. The membrane includes the nasal bridge, cheek and chin areas and is adapted to form a continuous seal over the nasal bridge, cheek and chin areas, respectively, of the patient's face. The nasal bridge area and the adjacent two cheek areas define an intersection or apex. The height of the membrane in the nasal bridge region at the intersection or apex is greater than the height of the adjacent portion of the cheek region.

Another aspect of the invention relates to a cushion for a patient interface for delivering breathable gas to a patient. The cushion comprises: a base wall configured to be connected to the frame; a lower support cushion which in use extends from the base wall towards the patient's face; and a membrane arranged to substantially cover the lower cushion at least partly. The membrane is adapted to form a continuous seal on the patient's face. The lower gasket has a spring-like connection to the base wall, the lower gasket and/or the base wall defining a spring constant that varies along the seal length.

Another aspect of the invention relates to a cushion for a patient interface for delivering breathable gas to a patient. The cushion comprises: a base wall configured to be connected to the frame; a lower support cushion which in use extends from the base wall towards the patient's face; and a membrane arranged to substantially cover the lower cushion at least partly. The membrane is adapted to form a continuous seal on the patient's face. One of the membrane and the lower gasket includes an outer surface defining an outer width of the gasket, and the base wall is offset inwardly relative to the outer surface.

Yet another aspect of the invention relates to a cushion for a patient interface for delivering breathable gas to a patient. The cushion comprises: a base wall configured to be connected to the frame; a lower support cushion which in use extends from the base wall towards the patient's face; and a membrane arranged to substantially cover the lower cushion at least partly. The membrane includes at least the bridge and alar regions of the nose adapted to form a continuous seal over the bridge and alar regions of the patient's face, respectively. The base wall and lower pad of the alar region are sloped or angled relative to the bottom of the frame.

Yet another aspect of the invention relates to a cushion for a patient interface for delivering breathable gas to a patient. The cushion comprises: a base wall configured to be connected to the frame; a lower support cushion which in use extends from the base wall towards the patient's face; and a membrane arranged to substantially cover the lower cushion at least partly. The membrane includes nasal bridge, nasal alar, upper cheek, lower cheek and chin areas adapted to form a continuous seal on the patient's face, respectively. The inner edge of the membrane defines an aperture to accommodate the patient's nose and mouth. The mouth width of the lower portion of the aperture that accommodates the patient's mouth remains substantially constant regardless of the facial height of the cushion.

Yet another aspect of the invention relates to a cushion for a patient interface for delivering breathable gas to a patient. The cushion comprises: a base wall configured to be connected to the frame; a lower support cushion which in use extends from the base wall towards the patient's face; and a membrane arranged to substantially cover the lower cushion at least partly. The membrane is adapted to form a continuous seal on the patient's face. At least a portion of the lower pad and/or the base wall has a lower portion that includes a resilient structure that limits displacement of the pad relative to a force applied from the frame.

Yet another aspect of the invention relates to a method of designing a series of mask assemblies. The method includes providing a first pad adapted to satisfy a wider range of patients; and providing a second pad adapted to fit a smaller range of patients. Each of the first and second pads includes an aperture to receive at least the patient's mouth, the apertures of the first and second pads having the same width.

Yet another aspect of the invention relates to a cushion for a patient interface for delivering a breathable gas to a patient. The cushion comprises: a base wall configured to be connected to the frame; a lower support cushion which in use extends from the base wall towards the patient's face; and a membrane arranged to substantially cover the lower cushion at least partly. The membrane includes at least a nasal bridge region adapted to form a continuous seal over the nasal bridge region of the patient's face. The membrane forms elongated ridges in the area of the bridge of the nose. The sloped sides of the elongated ridges meet to form the elongated top. The angle formed by each inclined side with the centerline of the top is in the range of 30 to 60°, and the radius of curvature of the top is in the range of 1.0 to 5.0 mm.

Yet another aspect of the invention relates to a cushion for a patient interface for delivering a breathable gas to a patient. The cushion comprises: a base wall configured to be connected to the frame; a lower support cushion which in use extends from the base wall towards the patient's face; and a membrane arranged to substantially cover the lower cushion at least partly. The membrane includes at least a nasal bridge region adapted to form a continuous seal over the nasal bridge region of the patient's face. The nasal bridge region of the membrane includes a profile that curves inwardly toward the cavity of the cushion along a radius to terminate at the inner edge of the membrane. The profile has a free end at an angle in the range of 30 to 50° with respect to the face contacting plane of the pad.

Yet another aspect of the invention relates to a cushion for a patient interface for delivering a breathable gas to a patient. The cushion comprises: a base wall configured to be connected to the frame; a lower support cushion which in use extends from the base wall towards the patient's face; and a membrane arranged to substantially cover the lower cushion at least partly. The membrane is adapted to form a continuous seal on the patient's face. The lower pad and/or base wall are question mark or sickle shaped.

Yet another aspect of the invention relates to a cushion for a patient interface for delivering a breathable gas to a patient. The cushion comprises: a base wall configured to be connected to the frame; a lower support cushion which in use extends from the base wall towards the patient's face; and a membrane arranged to substantially cover the lower cushion at least partly. The membrane is adapted to form a continuous seal on the patient's face. The arc structure of the lower pad includes an arc length greater than 16mm.

Yet another aspect of the invention relates to a cushion for a patient interface for delivering a breathable gas to a patient. The cushion comprises: a base wall configured to be connected to the frame; a lower support cushion which in use extends from the base wall towards the patient's face; and a membrane arranged to substantially cover the lower cushion at least partly. The membrane is adapted to form a continuous seal on the patient's face. The membrane includes a thickness that varies along the length of the seal.

Yet another aspect of the invention relates to a cushion for a patient interface for delivering a breathable gas to a patient. The cushion includes: a base wall configured to connect with the frame; and a membrane adapted to form a continuous seal on the patient's face. At least a portion of the base wall includes a tapered portion that tapers toward the membrane.

Yet another aspect of the present invention relates to a mask system comprising a set of at least two pads configured to fit different face sizes, wherein the at least two pads have substantially the same width.

Other aspects, features and advantages of the invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, which form a part of this disclosure and serve by way of example to illustrate the principles of the invention.

Description of drawings

The accompanying drawings facilitate the understanding of the various embodiments of the invention. In these drawings:

Figures 1 to 9 illustrate a cushion for a patient interface constructed in accordance with an embodiment of the present invention and showing exemplary dimensions of the embodiment;

Figures 10 to 14 are cross-sectional views of the liner shown in Figure 5;

Figure 15 is a front view of the liner shown in Figures 1 to 9 illustrating different areas of the liner;

Figures 16 to 17 illustrate another dimension of the liner shown in Figures 1 to 9;

Figures 18 to 19 illustrate yet another dimension of the pad shown in Figures 1 to 9;

Figures 20 to 21 illustrate yet another dimension of the pad shown in Figures 1 to 9;

Figure 22 is a cross-sectional view of the pad shown in Figures 1 to 9 illustrating parameters that can vary the spring characteristics of the lower pad;

Figures 23 to 29 are cross-sectional views of the liner shown in Figure 15 and illustrate exemplary parameters of an embodiment, the cross-sectional views illustrating only the lower liner;

30A to 30N are cross-sectional views illustrating alternative embodiments of liners according to the present invention;

Figures 31 to 32 are diagrams illustrating embodiments of the liner shown in Figures 1 to 9 and developed by ResMed Ltd. Full Face is a plot of the overall relationship between force and displacement in known pads sold commercially under the name;

Figure 33 is a graph illustrating the general relationship between force and displacement for different cross-sections of the pads shown in Figures 23 to 29;

Figure 34A illustrates the elastic lengths of the pads shown in Figures 1 to 9 and shows exemplary dimensions according to embodiments of the present invention;

FIG. 34B illustrates a diagram developed by ResMed Ltd. with Elastic lengths of known pads sold commercially under the name Full Face and illustrated Exemplary dimensions for Full Face;

Figure 35 is a side view of the liner shown in Figures 1 to 9;

Figures 36 to 37 are cross-sectional views of the liner shown in Figure 35;

Figure 38 is a front view of the pad shown in Figures 1 to 9, illustrating the flat portion of the pad;

Figure 38B is a diagram illustrating an embodiment of the liner shown in Figures 1 to 9 and developed by ResMed Ltd. Full Face is a graph of the overall relationship between force and displacement in the nasal bridge region of known cushions sold commercially under the name and states;

Figures 39-40B are front and cross-sectional views of the liner shown in Figures 1-9 and illustrate exemplary dimensions according to embodiments of the present invention;

Figures 41 to 45 are perspective views of the embodiment of the cushion shown in Figures 1 to 9 showing the rolling action of the nasal bridge region in use;

Figures 46 to 53 illustrate diagrams developed by ResMed Ltd. Full Face is a known liner sold commercially under the name;

54 to 58 illustrate a cushion for a patient interface according to another embodiment of the present invention and show exemplary dimensions of the embodiment;

Figures 59 to 63 are cross-sectional views of the liner shown in Figure 54;

Figure 64 is the same as developed by ResMed Ltd. Cross-sectional views of a portion (solid line portion) of the pads shown in FIGS. The relevant parts of can be represented by dotted lines, that is, there may be other different parts not shown);

65 is a cross-sectional view of a portion of the liner shown in FIGS. 54-58 showing exemplary dimensions according to an embodiment of the present invention;

Figures 66-69 are cross-sectional views of the liner shown in Figure 54 and illustrate exemplary dimensions in accordance with embodiments of the present invention;

Figures 70-71 are plan and cross-sectional views, respectively, of the liner shown in Figure 54, showing exemplary dimensions in accordance with embodiments of the present invention;

72 to 76 illustrate a cushion for a patient interface according to another embodiment of the present invention;

77 to 83 illustrate a cushion for a patient interface according to another embodiment of the present invention;

84 to 90 illustrate a cushion for a patient interface according to another embodiment of the present invention;

Figure 91 illustrates an alternative liner cross-section of the liner shown in Figure 34A;

Figure 92 illustrates another alternative liner cross-section of the liner shown in Figure 34A;

Figure 93 illustrates an alternative pad structure for the pad shown in Figure 15;

94A to 94C are a set of views depicting a horizontal cross-section through the nasal bridge region of the cushion of FIG. 35; and

95A to 95C are a set of views depicting a horizontal cross-section through the nasal bridge region of the prior art cushion of FIG. 51 .

detailed description

1 to 14 illustrate a liner 10 constructed in accordance with an embodiment of the present invention. Cushion 10 is adapted to be movably or permanently connected (eg, by mechanical and/or adhesive fastening) to a patient interface frame configured to deliver breathable gas to the patient. In an embodiment, the cushion 10 may be co-molded to the frame of the patient interface. In another embodiment, the pad may form part of a frame with an external support structure, such as Resmed's Hospital Nasal Mask. The cushion 10 provides a seal against the patient's face in use.

In the illustrated embodiment, the cushion 10 forms part of a full face mask. In particular, cushion 10 provides a seal around the patient's nose and mouth, thereby delivering breathable gas to the patient's nose and mouth. However, some aspects of the invention are applicable to other respiratory devices, such as nasal masks, oral masks, and the like. Liner 10 may be used with gussets as described in US Patent Application Serial No. 10/655,622, which is hereby incorporated by reference in its entirety.

Cushion 10 is configured to provide a more comfortable fit for a wide range of face shapes and sizes. Also, as described below, the gasket 10 is configured to provide a better seal and reduce the risk of air leaks.

As shown in FIGS. 1-14 , the cushion 10 includes a non-face-contacting portion 12 configured to connect to the frame of the patient interface, eg, by a friction fit, tongue-and-groove arrangement, etc., and a face-contacting portion 14 configured to engage the patient's face.

As best shown in FIGS. 5 and 15, preferably, the face-contacting portion 14 of the cushion 10 is generally triangular in shape and is configured to continuously contact the bridge of the nose, alar, upper cheek, lower cheek, and chin area of the patient. However, the face-engaging portion 14 may have other suitable shapes, such as a generally trapezoidal shape. In the illustrated embodiment, as best shown in FIG. 15 , the cushion 10 includes a nasal bridge region 16 to provide a seal along the bridge of the patient's nose, a pair of cheek regions 15 to provide a seal along the patient's nose, cheeks and mouth, and Chin area 20 to provide a seal along the patient's chin. A pair of cheek regions 15 can be further defined as a pair of alar regions 17 to provide a seal along the patient's alar, a pair of upper cheek regions 18 to provide a seal along the patient's upper cheeks, and a pair of lower cheek regions 19 to provide a seal along the patient's lower cheeks. seal with the patient's mouth.

The width of the pad in the lower cheek area and the face width to height ratio of the mask size

Cushion 10 is available in various sizes to accommodate various facial sizes. For example, Figures 16 to 21 illustrate three other sizes of liner 10 . In an embodiment, the liner 210 shown in Figures 16-17 may represent a particularly small size, the liner 310 shown in Figures 18-19 may represent a small size, and the liner 10 shown in Figures 1-14 may represent a medium size. Size, the liner 410 shown in Figures 20 to 21 may represent a large size. As shown, the mouth width of the cushion 10, 210, 310, 410 is constant substantially independent of its facial height.

In particular, the cushion 10 defines an aperture 22 that receives the patient's mouth. In a preferred embodiment, the lower portion of the hole 22 has a constant width for all pad sizes, eg 60mm. However, the width of the lower portion of the aperture 22 may be substantially constant for all pad sizes, such as in the range of 5 mm. For example, the width of the lower portion of the hole 22 of the gasket 10 may be 60 mm±5. Instead, ResMed Ltd. The width of the lower portion of the hole 722 of the known liner 700 sold under the name Full Face is 60mm for the large size, 54mm for the medium size and 52mm for the small size. Figures 46 to 53 show the Pad 700.

Anthropometric data indicate that patients with relatively small faces do not necessarily have narrower mouth widths than patients with relatively large faces. Therefore, all faces have substantially the same mouth width. The holes 22 in the cushion 10 are thus made wide enough to accommodate a wide range of patients and remain constant or substantially constant, for example within 5 mm, despite changes in face height of the mask to fit larger faces. This can be seen by the substantially constant pad geometry surrounding the lower cheek and chin regions of the different pad sizes, and the resulting variation in aspect ratio for the different pad sizes. For example, the lower portion of the hole 22 of each liner 10, 210, 310, 410 has substantially the same width.

Basal wall, subliner and membrane

As best shown in FIGS. 9 and 10 to 14, the face-contacting portion 14 of the pad 10 includes a base wall 28, a pair of lower support pads 30 extending from the base wall 28, and a pair of lower pads 30 arranged to substantially cover the lower pad 30. At least a portion of the membrane 32 provides a sealing structure for the face-contacting portion 14 . Base wall 28 and lower liner 30 provide a support structure for membrane 32 .

As shown, preferably, the lower pad 30 is provided only on the lateral sides of the base wall 28, such as in the alar, upper and lower cheek areas 17, 18, 19, although the lower pad 30 may engage or substantially surround the patient's Nose and lower lip or chin area. The lower pad 30 adds stiffness to the membrane 32 at the patient's mouth and cheeks. Although it is preferred that the membrane 32 be thinner than the lower liner 30, they may be of the same thickness or the membrane may be thicker than the lower liner. Also, removing the lower pad in the chin area 20 allows the pad 10 to engage the patient's face more closely in this area without subjecting the chin area 20 to excessive pressure. That is, there is no underlayment in this area to restrict the movement of the membrane 32, which improves the sealing of this area and adjacent areas. Additionally, the removal of the lower pad in the chin area 20 enables the pad 10 to accommodate more facial shapes and provides greater flexibility and allows movement and opening of the mouth.

In the illustrated embodiment, the face-contacting portion 14 of the cushion has a double-walled structure, membrane 32 and lower cushion 30, at the nose wings 17, upper cheek 18, and lower cheek area 19, and a membrane 32 at the bridge of the nose 16 and the chin area. 20 has a single-walled structure, that is, a membrane 32, as shown in FIGS. 10 to 14 . The single wall construction at the top and bottom of the pad 10 helps accommodate tall landmarks, such as a pointed chin, by bending the center of the pad 10 . This flexibility allows more patients to be satisfied with the same pad. However, the cushion 10 may have any other suitable structure, such as a single-wall, double-wall, triple-wall or more wall structure, in any suitable area of the cushion 10, such as the cheeks, chin, bridge of the nose. For example, lower pad 30 may extend around the entire perimeter of pad 10 . Also, the lower liner 30 can be completely removed.

As shown in FIGS. 10 to 14 , the thickness of the membrane may vary in different regions of the liner 10 . As shown, the thickness of the membrane in the bridge of the nose region 16 and upper cheek region 18 is 0.3 mm, the thickness of the membrane transitions to 0.5 mm in the upper cheek region 18 and remains in the lower cheek 19 and chin region 20 this thickness. This construction provides greater compliance/stretch on the bridge of the nose by providing a thinner membrane. The lower area does not require this stretch, and the thicker membrane here is less likely to flutter on the patient's face in use.

Inwardly offset base wall and frame connections

Another aspect of the invention relates to the size and configuration of the base wall 28 of the liner 10 , the lower liner 30 , and the membrane 32 . Figures 48 to 50 illustrate the The base wall 728 of the liner 700 , the lower liner 730 , and the membrane 732 . As shown in the figure, the cross-sectional figure of liner 10 and Pad 700 is different.

For example, as best shown in FIGS. 11-13 , the base wall 28 and frame connector 29 are offset inwardly relative to the outermost pad point 39 , such as the outer surface of the membrane or sub-pad. on the contrary, The base wall 728 and frame connector 729 of the cushion 700 are not offset inwardly relative to the outermost cushion point 739 (see FIGS. 48-50 ). As a result of this inward movement, the bottom width of the liner 10 is narrowed, for example by about 5mm or 2.5mm per bottom, which makes the liner less prominent and saves material, which means reduced weight and cost . Also, the narrower liner 10 provides less free length for the liner 10 to protrude outwardly in use, thereby helping to minimize or eliminate air leakage.

As shown in the figure, the lower portion of the lower pad 30 has a more curved structure, such as a semicircle, a question mark, or a sickle shape, and the structure defines a space 34 below the lower portion of the lower pad 30 and adjacent to the base wall 28. .

In the illustrated embodiment, the widest or outermost pad point of the pad is the outer surface of the lower pad 30, and the base wall 28 and frame connector 29 are offset inwardly relative to this point. Thus, by the design of the pad 10, particularly the curvature of the lower pad, the frames join at narrower points and thus the frame itself becomes narrower. This construction offers significant advantages in frame weight, perceived bulk and size. This configuration also minimizes dead space within the mask, which will help reduce CO2 rebreathing.

Additionally, the space 34 below the lower pad 30 allows for a greater range of motion of the lower pad 30 to add greater flexibility to the lower pad 30 and membrane 32 in use. In particular, the space 34 below the lower pad 30 enables greater displacement of the lower pad 30, for example with Pad 700 is substantially the same space restriction. Additionally, the space 34 enables greater displacement of the lower pad 30 before it begins to rise, thus reducing discomfort. Thus, the structure provides a more gradual force, increases comfort, and enables a seal to be obtained over a wider range of patients.

Variable spring constant (spring constant)

As shown, the lower pad 30 has a spring-like connection to the base wall 28 such that the lower pad 30 is movable relative to the base wall 28 . That is, the lower pad 30 can move into the space 34 (the lower pad 30 can also move into the space 33). The lower pad 30 and/or the base wall 28 may have any suitable spring constant that provides a spring force when the frame force is applied, and the lower pad 30 springs back to its original position when the frame force is released, and the spring constant may vary along the Anywhere its length is changed, for example by tapering and/or changing the thickness of the base wall 28 , changing the thickness of the middle and/or lower portion of the lower pad 30 . Likewise, the spring-like connection can extend along the entire lower pad 30, or the spring-like connection can also be located in a specific area, such as the cheekbone area.

Thus, a spring characteristic is combined with the base wall 28 and the lower pad 30 of the pad 10, the spring characteristic enables a continuously variable spring constant to be combined with the base wall 28 and the lower pad 30, such as the wall of each pad area. The stiffness can vary to meet the sealing needs of each area, which may vary due to the patient's underlying facial structure.

The spring properties of the base wall 28 and lower gasket 30 can be varied by varying a number of properties shown in FIG. 22 . For example, the spring characteristics can be changed by changing the height h of the lower pad, the thickness t, the radius r and the offset c of the lower pad. It should be understood that these parameters are exemplary only and that other parameters may be varied to vary the spring characteristics of the base wall 28 and lower gasket 30 .

23 to 29 illustrate parameters in an embodiment of the lower gasket 30 and base wall 28 to achieve the desired spring characteristics. As shown, lower gasket 30 and base wall 28 are configured to provide a variable spring constant around the perimeter of gasket 10 . That is, the spring constants of the lower pad 30 and the base wall 28 differ along the alar 17 , the upper cheek 18 , and the lower cheek region 19 . Although FIGS. 23 to 29 show specific parameters for the liner 10, it should be understood that these parameters are exemplary only and that other parameters are possible depending on the application.

In the nasal bridge region 16 (see, for example, FIG. 10 ), the lower pad 30 is absent in order to provide greater flexibility and the ability to conform to various face shapes. However, in an embodiment there may be a very soft spring-like lower pad 30 in this region.

In the alar region 17 (see FIGS. 23 to 24 ), in order to provide lateral stability thereby compressing the patient's alar and keeping the membrane 32 in contact with the cushion 30, the lower cushion 30 and base wall are provided with relatively stiff spring properties. 28. As shown, this structure is achieved by a relatively thick underpad, small height, and small radius. In the embodiment of the section shown in Fig. 23, h may be 12 mm, r may be 5 mm, t may be 2 to 3 mm, b may be 4 mm, w1 may be 11.5 mm, and w2 may be 8 mm. In the embodiment of the cross-section shown in Figure 24, h can be 14 mm, r can be 6 to 7 mm, t can be 2.5 mm, b can be 4 mm, w1 can be 11.5 mm, w2 can be 9.5 mm, and α can be 22°. It should be understood that these parameters are exemplary only and that other parameters are possible depending on the application.

Also, as best shown in FIG. 24, the base wall 28 and lower pad 30 of the alar region 17 are rotated approximately 22 degrees relative to the bottom of the frame. That is, the base wall 28 and lower pad 30 are sloped or angled at the alar region 17 of the pad 10 . This configuration further increases lateral stability and allows forces acting on the membrane to be applied perpendicularly to the patient's skin surface at the alae. This further assists the membrane 32 in contact with the patient's skin and prevents any air leaks. In a further embodiment, this angle may vary from 15 degrees to 30 degrees.

In the upper cheek area 18 (see FIGS. 25 to 26 ), due to the geometry of the lower pad, the lower pad 30 and base wall 28 have a stiffness that is less than it is in the alar area 17 and greater than that in the lower cheek area 19. hardness, which provides a stronger bone structure for the upper cheek. In the embodiment of the cross section shown in Figure 25, h may be 12 to 15 mm, preferably 13.5 mm, r may be 5 mm, t may be 2 mm, b may be 3 mm, and w1 may be 11.5 mm. In the embodiment of the cross section shown in Figure 26, h may be 12 to 15 mm, preferably 13.5 mm, r may be 5 mm, t may be 2 mm, b may be 3 mm, and w1 may be 11.5 mm. It should be understood that these parameters are exemplary only and that other parameters are possible depending on the application.

In the lower cheek region 19 (see FIGS. 27 to 29 ), the lower pad 30 and the base wall 28 have a relatively small spring constant. That is, the lower pad 30 of the lower cheek area 19 is relatively soft due to the easy deformation of the patient's muscular cheek area, thereby forming a seal with the pad with relatively little force. As shown, this structure is achieved by a larger height h, a larger radius r, and a thinner lower liner wall. In the embodiment of the cross-section shown in Fig. 27, h may be 14 mm, r1 may be 5 mm, r2 may be 7 mm, t may be 1.5 to 2 mm, b may be 3.5 mm, and w1 may be 11.5 mm. In the embodiment of the cross-section shown in Figure 28, h may be 16.5 mm, r1 may be 6 to 7 mm, r2 may be 8 mm, t may be 1.5 mm, b may be 3.5 mm, and w1 may be 11.5 mm. In the embodiment of the cross section shown in Figure 29, h may be 17.5 mm, r1 may be 6 to 7 mm, r2 may be 9 to 10 mm, t may be 1.5 mm, b may be 3.5 mm, and w1 may be 11.5 mm. It should be understood that these parameters are exemplary only and that other parameters are possible depending on the resulting application.

In the chin area 20 (see Fig. 14), no lower pad 30 is provided, although a more flexible elastic area could also be used. The chin area 20 provides an unrestricted membrane area that allows for lateral movement, mouth opening or movement, and accommodates a wide range of facial shapes.

Accordingly, pad 10 may be configured to provide different vertical and/or lateral stiffness in different regions of the pad. For example, in order to provide greater lateral stability at the patient's nose, the lateral stiffness of the alar regions 16, 17 is greater than the other regions.

Alternative Embodiments of Base Wall and Subliner

30A to 30N illustrate alternative embodiments of the base wall 28 and the lower liner 30 . Each of these embodiments provides a structure that allows flexibility of the lower pad 30 in use. In Fig. 30A, the lower cushion 30 defines an enclosed space 60, optionally filled with pressurized air, foam, gel or elastic material, adapted to inhibit movement of the lower cushion 30 in use. In Figure 30B, the space 34 below the lower cushion 30 is inside the breathing chamber. Likewise, the lower cushion 30 has an arc that curves from the interior of the breathing chamber toward the base wall 28 . However, the lower pad 30 may have any other suitable shape. For example, the lower pad 30 in Figure 30C is bulbous in shape and may be solid or hollow. In Fig. 30D, the lower pad 30 is generally Z-shaped. In Figures 30E and 30F, the lower pad 30 is bulbous (which may be solid or hollow) and the space 34 below the lower pad 30 has a ramp structure. In Figures 30C, 30E and 30F, the bulbous shape is optionally filled with pressurized air, foam, gel or elastic material and is adapted to inhibit movement of the lower cushion 30 in use. In Figure 30E, the ramp structure of the space 34 is suitable for guiding the lower liner 30 downwardly into the base wall 28 in use, and in Figure 30F, the ramp structure of the space 34 is suitable for guiding the lower liner 30 towards the into the breathing chamber. In Figures 30G, 30H and 30I, the lower pad 30 is generally T-shaped. Also, in FIGS. 30H and 30I , the base wall 28 defines an enclosed space 62 below the T-shaped lower liner 30 . Enclosed space 62 may optionally be filled with pressurized air, foam, gel or elastic material and is adapted to inhibit movement of lower cushion 30 in use. In addition, the spring constant can be changed by changing the pressure in the closed space 62 . In addition, the lower surface of the space 62 may have a ramp structure (as shown in FIG. 30H ) adapted to guide the lower cushion 30 inwardly into the breathing cavity in use. The lower surface of the enclosure 60 in FIG. 30A may also have a sloped configuration for orienting the lower gasket 30 in use. In Figures 30J and 30K, the lower pad 30 has an extended cross-sectional length for soft spring properties. Figure 30L illustrates a single wall structure with a lower liner 30 and no membrane. In FIG. 30M, the space 34 below the lower pad 30 is greatly increased. In FIG. 30N , the spring structure is disposed below the base wall 28 .

Displacement due to lower pad

when with Compared with the pad 700, the space 34 enables a greater displacement of the lower pad 30 under a predetermined amount of force. That is, the lower pad 30 provides greater movement for a given force. For example, Figure 31 illustrates a liner 10 and Overall force and displacement relationship between pads 700. As shown, the liner 10 curve ratio The exponential curve of pad 700 is smooth. Therefore, with The lower pad is less rigid and more compliant than the pad 700 . Note that space 34 may be filled with gel, silicone or other structures to alter the spring properties provided.

In addition, as shown in Figure 31, the displacement of the liner 10 at point B10 when it is fully compressed or begins to rise is greater than Pad 700 begins its upward displacement at point B700. Furthermore, the force at the point B10 at which the recovery begins is greater than at the point B700 at which the recovery begins. Thus, the pad 10 increases the force required to initiate rebound and provides a greater range of adjustment. Additionally, Figure 31 illustrates examples of maximum and minimum comfortable sealing forces, providing an example of the range of forces required to achieve a seal. As shown, the range of displacement A10 over this range of forces for liner 10 is substantially greater than that for Displacement A700 of pad 700 within this force range. Thus, the liner 10 allows a wide range of adjustment or displacement to achieve the seal and ensures that the sealing force is substantially less than the lift-back force so that the liner does not have to initiate lift-up to achieve the seal.

Fig. 32 illustrates liner 10 and Another example of the force and displacement relationship between pads 700, in which the slope of the straight portion of the curve of pad 10 is greater than the slope of the straight portion of the curve of pad 10 in FIG. The difference in slope can be attributed to the difference in the spring constant of the respective lower pads 30 . Thus, the pad shown in FIG. 31 has a greater displacement for a given force than the pad shown in FIG. 32 . Similarly, the liner 10 curve in Figure 32 is the same as The curves of the liner 700 intersect so that the liner 10 has more force at smaller displacements to ensure a seal and less force at greater displacements to maintain comfort over a greater range of displacement.

FIG. 33 illustrates another example of the relationship between force and displacement of the pad 10 . In this example, typical curves for different regions of the pad 10 are shown. In particular, one curve represents the cross-section of the alar region 17 in FIGS. 23 to 24, another curve represents the cross-section of the upper cheek 18 and lower cheek region 19 in FIGS. Cross-section of region 19. As shown, the underlying region of the liner 10 is softer or less rigid.

Extended elastic length of the lower pad

34A and 34B illustrate the extended length of the flexible lower liner 30 when compared with, for example The lower pad 30 is used to provide softer spring characteristics in selected areas of the pad 10 when compared to typical prior art pads of the pad 700 . The lengths a to b are deformable, thus providing a spring characteristic. As shown in the figure, due to the curvature of the lower pad 30, when combined with The lengths a to b (FIG. 34A) of liner 10 are considerably longer when compared to liner 700 (FIG. 34B). In the illustrated embodiment, the length a to b of the liner 10 is 22.84. However, in one embodiment, the length a to b of the liner 10 may be in the range of 16 to 30, preferably 20 to 25, most preferably 22 to 24. In another embodiment, the length a to b of the pad 10 may range from 16 to 20. Lengths b to c are relatively stiff and do not deform to provide spring characteristics. The additional length of the pad 10 is achieved by the arc of the lower pad 30, and the space 34 is a result of this shape. This additional length provides pad 10 with added flexibility and a greater range of motion. Figures 30J and 30K illustrate other embodiments that achieve greater section lengths.

Structure of the membrane in the nasal bridge area

The membrane is configured to form an effective seal around the bridge of the nose 16, alar 17, upper cheek 18, lower cheek 19 and chin area 20 of the patient. Another aspect of the invention relates to the configuration of the membrane 32 in the nasal bridge region 16 of the cushion 10 for improved sealing and comfort in this region.

In particular, as shown in the preferred embodiment in FIG. 36 and the alternative embodiment in FIG. 68 , the membrane 32 forms an elongated ridge 35 in the nasal bridge region 16 where the sloped sides 36 meet to form an elongated top 38 . Each sloped side 36 makes an angle in the range of 30 to 60°, preferably about 47°, from the centerline of the top. The radius of curvature of the top 38 is in the range of 1.0 to 5.0 mm, preferably about 2.5 mm. As shown, the lower pad 30 has been removed from under the membrane 32 in the bridge region 16, which allows the membrane 32 in this region to move freely between the lower pad 30 disposed in the alar region 17, As detailed below, this membranous structure creates a sharp inversion section upon engagement with the patient's nose, which improves the fit, comfort and seal of the nasal bridge region 16 . on the contrary, Pad 700 is relatively flat in this area (see Figure 52).

As shown in the preferred embodiment in FIG. 37 and the alternative embodiment in FIG. 69, the front end 40 of the elongated ridge 35 has an arcuate configuration. Front end 40 is configured to engage the patient's nasal bridge region and has a radius of curvature in the range of 1.5 to 7.0 mm, preferably about 4.0 mm.

Sharp cross-sectional profile in the nasal bridge area

As shown in Figure 10, the membrane 32 in the nasal bridge region 16 has a ratio The counterpart of liner 700 (see FIG. 48 ) has a sharper cross-sectional profile. In particular, the membrane 32 is provided with a large profile bent radially inwards towards the cavity of the liner to terminate at the inner edge of the membrane 32 . This structure more closely matches the contour or curvature of the patient's nasal bridge area. In the illustrated embodiment, the membrane 32 is angled relative to the face-contacting plane of the pad, eg, in the range of 30 to 50°. on the contrary, The corresponding angle of pad 700 is about 6°. This structure provides more comfort and a better fit for the patient.

the flat part of the bridge of the nose area

Figure 38 best shows that the nasal bridge region 16 has a substantially flat portion 50, such as at the apex of the curvature of the membrane, which, in front view, is deformable over a wide range, such as from a flat nasal bridge to a more pointed nasal bridge. Provides a more comfortable fit for the patient.

In particular, one aspect of the present invention provides a membrane 32 in the nasal bridge region 16 that will accommodate "flat faces," such as those of patients with low nasal bridges. To achieve this, the pad 10 has an upper point A that is higher than or level with point B (see FIG. 38 ). This height in the nasal bridge region 16 is combined with the rolled edge which keeps the surface area of the membrane 36 substantially flat relative to the patient's nasal bridge region. Keeping the surface area of the membrane 36 substantially flat relative to the patient's nasal bridge area prevents air leaks at the edges of the membrane.

Rolled edges also allow for movement to accommodate taller bridges. This configuration is achieved by not "stretching" the membrane which would cause discomfort and pain to the patient. For example, the displacement of the cushion 10 in the nasal bridge region 16 may be greater than about 40 mm, such as 41 mm. on the contrary, Cushion 700 provides approximately 20mm of displacement in the nasal bridge area. At these displacements, the membrane becomes very tight, the point in the force versus displacement plot where the force begins to increase dramatically at small displacements (see Figure 38B).

The displacement values of the pads in the nose bridge region in some prior art pads are as follows:

ResMed™ Nasal Cushion—16mm

Respironics Comfort Full Face Cushion—26mm

ResMed Bubble Nasal Mask Cushion—43mm

Healthdyne Soft Series Nasal Mask Cushion—17mm

The above displacement values are by no means an accurate representation of the depth of the nose that the pad will cover. Rather, these displacement values are merely an indication of the flexibility and/or extent of the membrane. So, for example with Pad 10 provides greater flexibility and/or a greater range of structure than pad 700 .

In the force versus displacement diagram for the membrane 32 in the nasal bridge region 16, large displacements occur with relatively small forces. For example, as shown in FIG. 38B, the cushion 10 provides a greater displacement in the nasal bridge region 16 than Displacement provided by pad 700 . This enables the cushion 10 to accommodate relatively deep nasal bridges in use. same, The as-molded (undeformed) cushion state (ie, no external force applied) of cushion 700 cannot comfortably accommodate a relatively flat or shallow bridge of the nose. In an embodiment, the membrane of the cushion 700 is broken to accommodate the face of a patient with a shallow nasal bridge. Therefore, liner 10 is also more than The pad 700 accommodates a wider range of nose bridge shapes.

In addition, as shown in FIG. 36, the profile of the membranous has a sharper tip than a flat profile or a saddle (eg, compared to the profile in FIG. 52). Liner 700 compared). Also, as shown in FIG. 35, the flat portion in the nasal bridge region 16 extends along a relatively flat plane P1 which is at an angle A to the plane P2 defining the frame attachment.

Thus, large displacements of shape (eg, tip), rolled edge, and height in the nose bridge region 16 occur with relatively little force. This configuration accommodates a wider range of patients, for example from those with a low nose bridge to those with a high nose bridge, while maintaining a seal against the patient's face with little force on the membrane.

Notably, the pad height can be varied around the pad perimeter to vary the flexibility or pad displacement in different regions of the pad. Figure 94C shows a reference dimension 940 for measuring pad height (also referred to as membrane height) - the height from the apex of the membrane to where the membrane touches the lower pad. Figure 95C shows a reference dimension 950 for measuring the pad height of a prior art pad.

pores in the membrane

As shown in Figures 39 to 40B, the inner edge of the membrane 32 defines the aperture 22 to accommodate the patient's nose and mouth. As shown, aperture 22 is generally triangular in shape. Likewise, the hole 22 has a circular recess 42, such as a keyhole. The notch 42 improves the seal in the nasal bridge area of various sizes and shapes, especially in patients with pointed noses. As shown in Figure 40A, the notch 42 has a radius of curvature in the range of 1.5 to 6.0 mm, preferably about 3.0 mm.

Rolling action of the nasal bridge area of the cushion in use

41 to 45 include freehand lines applied to the outer surface of the nasal bridge region 16 of the cushion 10 to illustrate the rolling action of the nasal bridge region 16 of the membrane 32 when engaged with the patient's nose. As noted above, the membrane 32 in the nasal bridge region 16 includes sloped sides 36 that meet to form the elongated top 38 shown in FIG. 41 . When the bridge of the patient's nose (simulated with a small rod) engages the nasal bridge region 16 of the membrane 32 (see FIG. 42 ), the membrane 32 creates a sharp inversion 44, wherein as the membrane 32 is positioned over the alar region 17 As the lower pad 30 moves between them, the inclined side 36 reverses its position. As the membrane 32 comes into closer contact with the bridge of the patient's nose, as shown in FIG. 43, the leading edge 46 of the inverted portion "rolls" toward the top of the liner 10 as the membrane 32 conforms to the patient's face. This configuration is advantageous because it enables the cushion 10 to accommodate patients with a wider range of nasal contours, including those with relatively small and relatively large root depths at the nose. Figures 44 and 45 show the nasal bridge region 16 of the membrane 32 in a fully inverted position. The sharply inverted portion 44 created by the engagement with the patient's nose provides a better seal and reduces the risk of creases and/or folds and associated discomfort and air leaks. That is, this structure replaces creases, which are detrimental to patient comfort and sealing, with rolls.

optional embodiment

Another embodiment of a liner 510 is illustrated in FIGS. 54 to 71 . In each figure, portions of liner 510 that are substantially similar to liner 10 are indicated by like reference numerals.

Figure 64 illustrates the base wall 528 of the liner 510, the lower liner 530, and the membrane 532 (shown in solid lines), compared to The base wall 728 of the gasket 700, the lower gasket 730, and the membrane 732 (indicated by dashed lines). As shown, the cross-sectional profile of liner 510 corresponds to Pad 700 is different.

For example, the membrane 532 is connected to the lower pad 530 at a lower position than The attachment location of the membrane of the liner 700 is more inward and upward. This structure basically removes the settings in the Vertically extending slot 731 in liner 700 . Also, this configuration makes the width of membrane 532 relative to The corresponding portion of the pad 700 is narrowed, for example in the range of 0 to 5, preferably about 2.5mm. As a result of this and the inward movement of the non-face contacting portion 512, this narrows the overall width of the pad 510 by about 5 mm, eg about 2.5 mm per base, which provides a pad with less protrusion and saves material. Also, the narrower membrane 532 provides less free length for the liner 510 in use, thus helping to minimize or eliminate air leakage. Further, base wall 528 and frame connector 529 are offset inwardly relative to the outermost pad point, eg, the outer surface of the lower pad. Figure 64 also shows that with The lengths a to b of liner 510 are longer when compared to liner 700 .

FIG. 65 shows further structural details and dimensions of one embodiment of the base wall 528 of the liner 510 , the lower liner 530 , and the membrane 532 . For example, the depth of the space 534 is in the range of 0 to 4.0mm, preferably about 3.0mm.

FIG. 68 illustrates elongated ridges 535 in the nasal bridge region 516. FIG. Each sloped side 536 makes an angle with the centerline of the top in the range of 30 to 60°, preferably about 47°. The radius of curvature of the top 538 is in the range of 1.0 to 5.0 mm, preferably about 2.5 mm. As shown in Figure 69, the radius of curvature of the front end 540 of the elongated ridge 535 is in the range of 1.5 to 7.0mm, preferably about 4.0mm.

70 and 71 illustrate a flat portion 550 in the nose bridge region 516 of the cushion 510 . Likewise, as shown in FIG. 71, the membrane 532 in the nose bridge region 516 has a first portion having a radius of curvature in the range of 50 to 80 mm, preferably about 65 mm, and a second portion having a radius of curvature of 5.5 to 9.5 mm. mm, preferably about 7.5 mm. In the illustrated embodiment, the membrane 532 is angled in the range of 30 to 50°, preferably about 40°, relative to the face contacting plane of the pad.

Another embodiment of a liner 610 is illustrated in FIGS. 72 to 76 . As best shown in FIG. 76 , the liner includes at least a base wall 628 and a membrane 632 . As shown, the length of the membrane 632 in the nasal bridge region (eg, the cross-sectional length of the membrane) may vary. For example, the length of the membrane in the area of the bridge of the nose may be chosen to be a shorter length L1 or a longer length L2.

As shown in Figures 74 and 75, when worn on the patient's face, the membrane length controls the distance the displaced cushion membrane slides over the patient's nose (indicated by the dashed line on the contour of the patient's face). This configuration avoids the possibility of any excess cushion membrane sliding down the patient's nose too much (eg, especially in patients with shallow nasal bridge depths), which would cause facial discomfort and skin markings at the patient's nose.

77 to 83 illustrate another embodiment of a liner 810 . The liner 810 includes a base wall 828 , a lower support liner 830 and a membrane 832 . As described above, preferably, the lower pad 830 is provided only on the lateral side of the pad 810 .

The base wall 828 may be offset inwardly relative to the outermost pad point, such as the membrane or the outer surface of the subpad. This structure provides spring characteristics that can be varied around the perimeter of the pad to vary pad flexibility (lateral and/or vertical) around the perimeter of the pad, for example pad stiffness can be varied within each pad area to accommodate Sealing needs in each region, which may vary due to the patient's underlying facial structure. That is, the level along the side of the pad may change if there is a deviation (eg from "firm" to "soft").

For example, FIGS. 77 to 83 illustrate cross-sections through three distinct regions R1, R2, R3 in a gasket 810, as shown in FIG. Outer surface 880 is relatively straight. This provides a minimum elastic component, eg stiff or rigid, in region R1.

As shown in FIG. 82, base wall 828, lower liner 830, and membrane 832 collectively define an outer surface 882 that transitions from a relatively straight configuration to a curved configuration. This provides a relatively small deflection for the more flexible elastic member compared to region R1.

As shown in FIG. 83 , base wall 828 , lower liner 830 , and membrane 832 collectively define an outer surface 884 that curves outwardly from base wall 828 . This provides a relatively large excursion for optimum elastic components in region R3, such as pliable or flexible properties.

Accordingly, the cushion 810 can be designed to provide varying degrees of flexibility around its circumference, which allows the cushion 810 to conform to a variety of face shapes.

84 to 90 illustrate another embodiment of a liner 910 . The liner 910 includes a support liner 930 under the base wall 928 and a membrane 932 . As shown, preferably, the lower pad 930 is provided only on the lateral sides of the pad 910, eg, there is no lower pad in the nose bridge and chin area (see FIG. 88).

As shown in FIG. 90 , compared to FIG. 89 , the base wall 928 includes a tapered portion 990 that tapers toward the membrane 932 . This structure increases plasticity.

FIG. 91 illustrates an alternative structure of the liner 10 in FIG. 34A (the structure indicated by the dashed line in FIG. 34A ). As shown, material is removed from sidewall 28, and space or void 34 is reduced relative to the structure in FIG. 34A. This configuration of Figure 91 increases the displacement relative to the previous displacement in Figure 34A. The increased displacement is achieved by changing the geometry of the sidewall 28 . Notably, the void 34 may be variable or constant around the perimeter of the liner.

FIG. 92 illustrates an alternative structure of the liner 10 in FIG. 34A (the structure indicated by the dashed line in FIG. 34A ). As shown, some material is removed from sidewall 28 and space or void 34 is reduced relative to the structure in FIG. 34A. This configuration of Figure 92 increases the displacement relative to the previous displacement in Figure 34A. The increased displacement is achieved by changing the geometry of the sidewall 28 . This configuration may require thickening of the cross-section of the base wall 28 to increase stiffness around the perimeter of the liner or locally. When required, stiffening can be achieved by localized auxiliary strips.

FIG. 93 illustrates an alternative configuration of the liner 10 shown in FIG. 15 . As shown, the keyhole-shaped cutout (to accommodate the patient's nasal bridge area) can grow larger as the mask size decreases. For example, a very small size mask has a larger cutout than a large size mask.

Notably, the cross-sectional design of a specific area of the patient's face (eg, FIGS. 23 to 29 ) can be within a specific area or any area around the perimeter of the cushion. That is, the cross-sectional design should not be limited to a specific area. Likewise, the cross-sections shown in Figures 91 and 92 can be applied at any point around the perimeter of the pad.

While the present invention has been described with reference to what are presently considered to be the most practical and preferred embodiments, it is to be understood that the invention should not be limited to the disclosed embodiments, but on the contrary, the invention is intended to cover within the spirit and scope of the present invention Various modifications and equivalent structures are included. Likewise, various implementations described above can be implemented in combination with other embodiments, for example, aspects of one embodiment can be combined with aspects of another embodiment to achieve yet another embodiment. Furthermore, while the present invention has particular application to patients suffering from OSA, it should be appreciated that patients suffering from other diseases (eg, cardiac congestion failure, diabetes, morbid obesity, snoring, barriatric surgery, etc.) may benefit from the above teachings. Furthermore, the above teachings have applicability to patients and non-patients alike in non-medical applications.

Claims (96)

CLAIMS 1. A cushion for a patient interface for delivering a breathable gas to a patient, said cushion comprising: a base wall configured to connect with the frame; a lower support cushion extending, in use, from said base wall towards the patient's face; and a membrane configured to substantially cover at least a portion of the lower cushion, the membrane including the nasal bridge, cheek and chin regions adapted to form a continuous seal respectively in the nasal bridge, cheek and chin regions of the patient's face, the nasal bridge and adjacent The two cheek regions define the intersection, Wherein the height of the membrane in the bridge of the nose region at the intersection is greater than the height of the adjacent portion of the cheek region. 2. The cushion of claim 1, wherein the membrane of the nasal bridge region has rolled edges. 3. A pad as claimed in any one of claims 1 to 2, wherein the height is measured at the apex of the intersection. 4. A pad as claimed in any one of claims 1 to 3, wherein the lower pad is provided only laterally to the base wall in the buccal region of the membrane. 5. A cushion for a patient interface for delivering a breathable gas to a patient, the cushion comprising: a base wall configured to connect with the frame; a lower support cushion extending, in use, from said base wall towards the patient's face; and a membrane positioned to substantially cover at least a portion of the lower cushion, the membrane adapted to form a continuous seal on the patient's face, Where the lower gasket has a spring-like connection to the base wall, the lower gasket and/or the base wall define a spring constant that varies along the length of the seal. 6. The gasket of claim 5, wherein the membrane includes five distinct regions, and at least three of the five distinct regions have different spring constants. 7. The cushion of any one of claims 5 to 6, wherein the cushion is a nasal cushion. 8. The cushion of claim 7, wherein the membrane includes nasal bridge, nasal alar and upper lip regions adapted to form a continuous seal on the patient's face respectively in the nasal bridge, nasal alar and upper lip regions. 9. The cushion of any one of claims 5 to 6, wherein the cushion is a full face cushion. 10. The cushion of claim 9, wherein said membrane comprises nasal bridge, nasal alar, upper cheek, lower cheek and chin area. 11. The pad of claim 10, wherein the lower pad is disposed only laterally of the base wall of the alar, upper cheek, and lower cheek regions. 12. A pad as claimed in any one of claims 10 to 11 wherein the lower pad is less rigid in the upper and lower cheek regions than in the alar region. 13. A pad as claimed in any one of claims 10 to 12, wherein the lower pad is stiffer in the lower cheek region than in the upper cheek region. 14. A pad as claimed in any one of claims 5 to 13, wherein at least a portion of the lower pad and/or base wall has a lower portion comprising a resilient structure that defines the pad relative to the The displacement of the force applied by the frame. 15. A pad as claimed in any one of claims 5 to 14, wherein the lower pad and/or base wall are question mark or sickle shaped. 16. A pad as claimed in any one of claims 5 to 15, wherein the spring characteristic of the lower pad is determined by the lower pad height, the lower pad thickness, the lower pad radius and the lower pad offset At least one determination of . 17. A cushion for a patient interface for delivering a breathable gas to a patient, the cushion comprising: a base wall configured to connect with the frame; a lower support cushion extending, in use, from said base wall towards the patient's face; and a membrane positioned to substantially cover at least a portion of the lower cushion, the membrane adapted to form a continuous seal on the patient's face, Wherein one of the membrane and the lower gasket includes an outer surface defining an outer width of the gasket, and the base wall is offset inwardly relative to the outer surface. 18. The gasket of claim 17, wherein the depth of the inner offset of the base wall is different in different regions of the gasket, and the depth at least partially determines the spring-like characteristic. 19. The cushion of any one of claims 17 to 18, wherein the cushion is a nasal cushion. 20. The cushion of claim 19, wherein the membrane includes nasal bridge, nasal alar and upper lip regions adapted to form a continuous seal on the patient's face respectively in the nasal bridge, nasal alar and upper lip regions. 21. The cushion of any one of claims 17 to 18, wherein the cushion is a full face cushion. 22. The cushion of claim 21, wherein said membrane comprises nasal bridge, nasal alar, upper cheek, lower cheek and chin area. 23. The pad of claim 22, wherein the lower pad is disposed only laterally of the base wall of the alar, upper cheek, and lower cheek regions. 24. A pad as claimed in any one of claims 17 to 23, wherein the lower pad provides an outer surface. 25. A pad as claimed in any one of claims 17 to 24, wherein at least part of the lower pad and/or base wall has a lower portion comprising a resilient structure that defines the relative The displacement of the force applied by the frame. 26. A cushion as claimed in any one of claims 17 to 25, wherein the lower cushion and/or base wall is in the shape of a question mark or a sickle. 27. A cushion for a patient interface for delivering a breathable gas to a patient, the cushion comprising: a base wall configured to connect with the frame; a lower support cushion extending, in use, from said base wall towards the patient's face; and a membrane configured to substantially cover at least a portion of the lower cushion, the membrane including at least bridge and alar regions adapted to form a continuous seal over the bridge and alar regions of the patient's face, respectively, Wherein the base wall and lower pad of the alar region are sloped or angled relative to the bottom of the frame. 28. The cushion of claim 27, wherein the cushion is a nasal cushion. 29. The cushion of claim 28, wherein the membrane includes nasal bridge, nasal alar and upper lip regions adapted to form a continuous seal on the patient's face respectively. 30. The cushion of claim 27, wherein said cushion is a full face cushion. 31. The cushion of claim 30, wherein said membrane comprises nasal bridge, nasal alar, upper cheek, lower cheek and chin area. 32. A cushion as claimed in any one of claims 27 to 31 wherein the angle between the base wall of the alar region and the lower cushion relative to the frame bottom is in the range of 15 to 25 degrees. 33. The cushion of claim 32, wherein the base wall of the alar region and the lower cushion form an angle of 22 degrees with respect to the bottom of the frame. 34. A cushion for a patient interface for delivering a breathable gas to a patient, the cushion comprising: a base wall configured to connect with the frame; a lower support cushion extending, in use, from said base wall towards the patient's face; and a membrane configured to substantially cover at least a portion of the lower cushion, the membrane comprising the bridge of the nose, wings of the nose, upper cheeks, lower cheeks and chin area, Wherein the inner edge of the membrane defines an aperture to accommodate the patient's nose and mouth, and the mouth width of the lower portion of the aperture to accommodate the patient's mouth remains substantially constant regardless of the facial height of the cushion. 35. The pad of claim 34, wherein the mouth width is constant for all pad sizes. 36. A pad as claimed in claim 35 wherein the mouth width is 60mm for all pad sizes. 37. The pad of claim 34, wherein the mouth width is substantially constant for all pad sizes. 38. The pad of claim 37, wherein the mouth width is 60 mm ± 5 for all pad sizes. 39. A pad as claimed in any one of claims 34 to 38, wherein the apertures are generally triangular in shape. 40. The pad of any one of claims 34 to 39, wherein the mouth width is greater than about 54mm. 41. A cushion for a patient interface for delivering a breathable gas to a patient, the cushion comprising: a base wall configured to connect with the frame; a lower support cushion extending, in use, from said base wall towards the patient's face; and a membrane positioned to substantially cover at least a portion of the lower cushion, the membrane adapted to form a continuous seal on the patient's face, Wherein the lower pad and/or at least a portion of the base wall has a lower portion comprising a resilient structure that limits displacement of the pad relative to a force applied from the frame. 42. The cushion of claim 41, wherein said cushion is a nasal cushion. 43. The cushion of claim 42, wherein the membrane includes nasal bridge, nasal alar and upper lip regions adapted to form a continuous seal on the patient's face respectively. 44. The cushion of claim 41, wherein said cushion is a full face cushion. 45. The cushion of claim 44, wherein said membrane comprises nasal bridge, nasal alar, upper cheek, lower cheek and chin area. 46. A pad as claimed in any one of claims 41 to 45, wherein the lower pad has a spring-like connection to the base wall. 47. A pad as claimed in any one of claims 41 to 46, wherein the membrane has free ends spaced vertically and horizontally from the free ends of the lower pad. 48. A pad as claimed in any one of claims 41 to 47, wherein the lower portion of the lower pad has a substantially arcuate configuration defining Flex space for the location of the wall. 49. The pad of claim 48, wherein the void has a depth of less than about 4.0 mm. 50. The pad of claim 49, wherein the void has a depth of about 3.0 mm. 51. The cushion of any one of claims 44 to 50, wherein the inner edge of the membrane defines a generally triangular-shaped aperture for receiving the patient's nose and mouth, and the apex of the aperture has a curvature Cutouts with radii ranging from 1.5 to 6.0mm. 52. The pad of claim 51, wherein the cutout has a radius of curvature of about 3.0 mm. 53. The cushion of any one of claims 45 to 52, wherein the lower cushion is disposed only laterally to the base wall of the alar, upper cheek and lower cheek regions of the membrane. 54. A pad as claimed in any one of claims 45 to 53, wherein the membrane forms elongated ridges in the bridge of the nose region, the sloped sides of the elongated ridges meeting to form an elongated top, wherein each sloped side The angles formed with the centerline of the top are all in the range of 30 to 60°, and the radius of curvature of the top is in the range of 1.0 to 5.0 mm. 55. A pad as claimed in claim 54, wherein each of said sloped sides forms an angle with the centerline of the top of about 40° to 50°, preferably 47°, and the top has a radius of curvature of about 2.5mm . 56. A pad as claimed in any one of claims 54 to 55 wherein the front portion of the elongated ridge has an arcuate configuration with a radius of curvature in the range of 1.5 to 7.0mm. 57. The pad of claim 56, wherein the front portion has a radius of curvature of about 4.0 mm. 58. The cushion of any one of claims 54 to 57, wherein the elongated ridges are configured to invert their configuration when engaged with the patient's nasal bridge region. 59. The pad of claim 58, wherein the leading edge of the elongated ridge is adapted to roll as the elongated ridge reverses its configuration. 60. The pad of any one of claims 46 to 59, wherein the nasal bridge region of the membrane includes a contour that curves radially inward toward the cavity of the pad so as to The inner edge of the membrane ends, the profile having a free end at an angle in the range of 30 to 50° with respect to the face contact plane of the pad. 61. The pad of claim 60, wherein the contoured portion is angled at about 40° relative to a face-contacting plane of the pad. 62. A cushion as claimed in any one of claims 41 to 61, wherein the lower cushion and/or base wall is in the shape of a question mark or a sickle. 63. The cushion of any one of claims 44 to 62, wherein the inner edge of the membrane defines a generally triangular-shaped aperture for receiving the patient's nose and mouth, and the aperture for receiving the patient's mouth The lower portion has a width greater than about 54mm. 64. A cushion as claimed in any one of claims 43 and 45 to 63, wherein the membrane of the nasal bridge region has a substantially flat portion in front view. 65. A method of designing a series of mask assemblies comprising: providing a first liner suitable for a wider range of patients; and Provides a secondary liner adapted to meet a narrower range of patients, Where each of the first and second pads includes an aperture to receive at least the patient's mouth, the apertures of the first and second pads have the same width. 66. A cushion for a patient interface for delivering a breathable gas to a patient, the cushion comprising: a base wall configured to connect with the frame; a lower support cushion extending, in use, from said base wall towards the patient's face; and a membrane configured to substantially cover at least a portion of the lower cushion, the membrane including at least a nasal bridge region adapted to form a continuous seal over the nasal bridge region of the patient's face, wherein the membrane forms an elongated ridge in the area of the bridge of the nose, the sloping sides of the elongated ridge meet to form an elongated top, wherein each sloping side forms an angle with the centerline of the top in the range of 30 to 60°, And the radius of curvature of the top is in the range of 1.0 to 5.0 mm. 67. The cushion of claim 66, wherein the cushion is a nasal cushion. 68. The cushion of claim 67, wherein the membrane includes nasal bridge, nasal alar and upper lip regions adapted to form a continuous seal on the patient's face respectively. 69. The cushion of claim 66, wherein the cushion is a full face cushion. 70. The cushion of claim 69, wherein said membrane comprises nasal bridge, nasal alar, upper cheek, lower cheek, lower cheek and chin area. 71. A cushion for a patient interface for delivering a breathable gas to a patient, the cushion comprising: a base wall configured to connect with the frame; a lower support cushion extending, in use, from said base wall towards the patient's face; and a membrane configured to substantially cover at least a portion of the lower cushion, the membrane including at least a nasal bridge region adapted to form a continuous seal over the nasal bridge region of the patient's face, Wherein the nasal bridge region of the membrane includes a profile that curves radially inward towards the cavity of the cushion to terminate at the inner edge of the membrane, the profile having a free end opposite to The face contacting plane of the pad subtends an angle in the range of 30 to 50°. 72. The cushion of claim 71, wherein the cushion is a nasal cushion. 73. The cushion of claim 72, wherein the membrane includes nasal bridge, nasal alar and upper lip regions adapted to form a continuous seal on the patient's face respectively. 74. The cushion of claim 71, wherein the cushion is a full face cushion. 75. The cushion of claim 74, wherein said membrane comprises nasal bridge, nasal alar, upper cheek, lower cheek and chin area. 76. A cushion for a patient interface for delivering a breathable gas to a patient, the cushion comprising: a base wall configured to connect with the frame; a lower support cushion extending, in use, from said base wall towards the patient's face; and a membrane positioned to substantially cover at least a portion of the lower cushion, the membrane adapted to form a continuous seal on the patient's face, Wherein the lower liner and/or the base wall are in the shape of a question mark or a sickle. 77. The cushion of claim 76, wherein the cushion is a nasal cushion. 78. The cushion of claim 77, wherein the membrane includes nasal bridge, nasal alar and upper lip regions adapted to form a continuous seal on the patient's face respectively. 79. The cushion of claim 76, wherein the cushion is a full face cushion. 80. The cushion of claim 79, wherein said membrane comprises nasal bridge, nasal alar, upper cheek, lower cheek and chin areas adapted to form a continuous seal on the patient's face, respectively. cheek and chin area. 81. A cushion as claimed in any one of claims 76 to 80, wherein the lower cushion and/or base wall comprises a straight portion and a curved portion, and the straight portion has a vertical axis. 82. A cushion for a patient interface for delivering a breathable gas to a patient, the cushion comprising: a base wall configured to connect with the frame; a lower support cushion extending, in use, from said base wall towards the patient's face; and a membrane positioned to substantially cover at least a portion of the lower cushion, the membrane adapted to form a continuous seal on the patient's face, Wherein the arc structure of the lower pad includes an arc length greater than 16mm. 83. The pad of claim 82, wherein the arc length is in the range of 16 to 30mm. 84. A pad as claimed in any one of claims 82 to 83 wherein the arc length is in the range of 20 to 25mm. 85. A pad as claimed in any one of claims 82 to 84 wherein the arc length is in the range of 22 to 24mm. 86. The pad of any one of claims 82 to 85, wherein the arc length is 22.84 mm. 87. A pad as claimed in any one of claims 82 to 83 wherein the arc length is in the range of 16 to 20mm. 88. A cushion for a patient interface for delivering a breathable gas to a patient, the cushion comprising: a base wall configured to connect with the frame; a lower support cushion extending, in use, from said base wall towards the patient's face; and a membrane positioned to substantially cover at least a portion of the lower cushion, the membrane adapted to form a continuous seal on the patient's face, wherein said membrane comprises a thickness that varies along the length of said seal. 89. The cushion of claim 88, wherein the cushion is a nasal cushion. 90. The cushion of claim 89, wherein the membrane includes nasal bridge, nasal alar and upper lip regions adapted to form a continuous seal on the patient's face respectively. 91. The cushion of claim 88, wherein the cushion is a full face cushion. 92. The cushion of claim 91, wherein said membrane comprises nasal bridge, nasal alar, upper cheek, lower cheek and chin area. 93. The cushion of claim 92, wherein said membrane has a thickness of 0.3 mm in the nose bridge area and upper cheek area, said thickness transitions to 0.5 mm in the upper cheek area, and remains in the lower cheek and chin area. 0.5mm thickness. 94. A cushion for a patient interface for delivering a breathable gas to a patient, the cushion comprising: a base wall configured to connect with the frame; and a membrane adapted to form a continuous seal on the patient's face, Wherein at least a portion of the base wall includes a tapered portion that tapers toward the membrane. 95. The cushion of claim 94, wherein the tapered portion is disposed in the nasal bridge region. 96. A mask system comprising: a set of at least two pads configured to fit different face sizes, Wherein said at least two pads have substantially the same width.